# K993491: Quickpac II One Step Opiates Test

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Oct 29, 1999 after 14 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Syntron’s QuikPac II One Step Opiates assay is a rapid, qualitative, competitive binding-immunoassay for the determination of Opiates in urine at the cutoff level of 2000 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicatedé. Syntron’s QuikPac II One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.

Source page: https://510kreport.com/device/K993491
Methodology: https://510kreport.com/methodology